{"title":"基于hpv的多种“筛选和分诊”算法在中国农村现实环境中的评估。","authors":"Remila Rezhake, Guzhanuer Abuduxikuer, Guligeina Abudurexiti, Qian Zhuo, Kadeliya Muhetaer, Tangnuer Abulimiti, Yumei Ouyang, Wenyun Li, Jing Yang, Gulixian Tuerxun, Fanghui Zhao, Guzhalinuer Abulizi, Marc Arbyn","doi":"10.20892/j.issn.2095-3941.2025.0384","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>Drawbacks of human papillomavirus (HPV) primary screening, including high referral rates and low specificity, highlight the necessity for triage strategies to balance the screening benefits with potential harms.</p><p><strong>Methods: </strong>A cross-sectional, population-based diagnostic study was conducted in rural Xinjiang, China involving 8,638 women ≥ 25 years of age who participated in organized cervical cancer screening between 2023 and 2024. The study evaluated the accuracy and efficiency of multiple HPV-based \"screen-triage\" strategies. Histologically confirmed cervical intraepithelial neoplasia grade 2 or worse (CIN2+ and CIN3+) served as disease outcomes.</p><p><strong>Results: </strong>Among single-step triage strategies, only extended genotyping for the seven most carcinogenic HPV types (HPV16/18/31/33/45/52/58) maintained sensitivity for CIN2+ comparable to HPV screening without triage (90.0% <i>vs.</i> 92.5%, <i>P</i> = 0.50) but significantly improved specificity (94.7% <i>vs</i>. 90.8%, <i>P</i> < 0.001). This approach led to a 38% reduction in colposcopy referrals (relative rate, 0.62; 95% CI: 0.59-0.65). Two-step triage algorithms (HPV16/18 with reflex ASC-US+ or methylation) showed slightly lower but non-significant sensitivity (87.5%, <i>P</i> = 0.13/89.6%, <i>P</i> =0.50) than HPV primary screening without triage, yet achieved significantly increased specificity (> 95%, <i>P</i> < 0.001) and reduced colposcopy referral by ~50% (relative rate, 0.5; <i>P</i> < 0.001). If negative for cytology or methylation, women positive for 12 high-risk HPV types (excluding HPV16/18) had a < 2% risk of CIN2+ (CIN3+ risk < 1%), indicating delayed follow-up.</p><p><strong>Conclusions: </strong>Focusing on the seven high-risk HPV types within a one-step \"screen-triage\" framework effectively balances minimal sensitivity loss with significant gains in specificity, reducing unnecessary referrals and treatments, especially valuable in resource-limited settings. Integrating HPV genotyping with methylation results improves the accurate identification of women requiring immediate referral, which is advisable when resources allow.</p>","PeriodicalId":9611,"journal":{"name":"Cancer Biology & Medicine","volume":"22 9","pages":""},"PeriodicalIF":8.4000,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12501896/pdf/","citationCount":"0","resultStr":"{\"title\":\"Evaluation of the multiple HPV-based \\\"screen and triage\\\" algorithms in real-world settings of rural China.\",\"authors\":\"Remila Rezhake, Guzhanuer Abuduxikuer, Guligeina Abudurexiti, Qian Zhuo, Kadeliya Muhetaer, Tangnuer Abulimiti, Yumei Ouyang, Wenyun Li, Jing Yang, Gulixian Tuerxun, Fanghui Zhao, Guzhalinuer Abulizi, Marc Arbyn\",\"doi\":\"10.20892/j.issn.2095-3941.2025.0384\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>Drawbacks of human papillomavirus (HPV) primary screening, including high referral rates and low specificity, highlight the necessity for triage strategies to balance the screening benefits with potential harms.</p><p><strong>Methods: </strong>A cross-sectional, population-based diagnostic study was conducted in rural Xinjiang, China involving 8,638 women ≥ 25 years of age who participated in organized cervical cancer screening between 2023 and 2024. The study evaluated the accuracy and efficiency of multiple HPV-based \\\"screen-triage\\\" strategies. Histologically confirmed cervical intraepithelial neoplasia grade 2 or worse (CIN2+ and CIN3+) served as disease outcomes.</p><p><strong>Results: </strong>Among single-step triage strategies, only extended genotyping for the seven most carcinogenic HPV types (HPV16/18/31/33/45/52/58) maintained sensitivity for CIN2+ comparable to HPV screening without triage (90.0% <i>vs.</i> 92.5%, <i>P</i> = 0.50) but significantly improved specificity (94.7% <i>vs</i>. 90.8%, <i>P</i> < 0.001). This approach led to a 38% reduction in colposcopy referrals (relative rate, 0.62; 95% CI: 0.59-0.65). Two-step triage algorithms (HPV16/18 with reflex ASC-US+ or methylation) showed slightly lower but non-significant sensitivity (87.5%, <i>P</i> = 0.13/89.6%, <i>P</i> =0.50) than HPV primary screening without triage, yet achieved significantly increased specificity (> 95%, <i>P</i> < 0.001) and reduced colposcopy referral by ~50% (relative rate, 0.5; <i>P</i> < 0.001). If negative for cytology or methylation, women positive for 12 high-risk HPV types (excluding HPV16/18) had a < 2% risk of CIN2+ (CIN3+ risk < 1%), indicating delayed follow-up.</p><p><strong>Conclusions: </strong>Focusing on the seven high-risk HPV types within a one-step \\\"screen-triage\\\" framework effectively balances minimal sensitivity loss with significant gains in specificity, reducing unnecessary referrals and treatments, especially valuable in resource-limited settings. 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引用次数: 0
摘要
目的：人乳头瘤病毒（HPV）初级筛查的缺点，包括转诊率高和特异性低，突出了筛选策略的必要性，以平衡筛查的好处和潜在的危害。方法：在中国新疆农村开展了一项基于人群的横断面诊断研究，涉及8638名年龄≥25岁的妇女，她们于2023年至2024年参加了有组织的宫颈癌筛查。该研究评估了多种基于hpv的“筛选分诊”策略的准确性和效率。组织学证实宫颈上皮内瘤变2级或更严重（CIN2+和CIN3+）作为疾病结局。结果：在单步分诊策略中，对于7种最具致癌性的HPV类型（HPV16/18/31/33/45/52/58），仅扩展基因分型对CIN2+的敏感性与未分诊的HPV筛查相当（90.0% vs 92.5%, P = 0.50），但特异性显著提高（94.7% vs 90.8%, P < 0.001）。这种方法导致阴道镜转诊减少38%（相对率，0.62;95% CI: 0.59-0.65）。两步分诊算法（HPV16/18伴ASC-US+或甲基化）的敏感性（87.5%,P = 0.13/89.6%, P =0.50）略低于未分诊的HPV初筛，但特异性显著提高（bb0 95%, P < 0.001），阴道镜转诊减少约50%（相对率，0.5,P < 0.001）。如果细胞学或甲基化阴性，12种高危HPV类型（不包括HPV16/18）阳性的女性CIN2+风险< 2% (CIN3+风险< 1%)，表明随访延迟。结论：在一步“筛查分诊”框架内关注7种高危HPV类型，有效地平衡了最小的敏感性损失和显著的特异性增益，减少了不必要的转诊和治疗，在资源有限的情况下尤其有价值。整合HPV基因分型与甲基化结果提高了需要立即转诊的妇女的准确识别，在资源允许的情况下，这是可取的。
Evaluation of the multiple HPV-based "screen and triage" algorithms in real-world settings of rural China.
Objective: Drawbacks of human papillomavirus (HPV) primary screening, including high referral rates and low specificity, highlight the necessity for triage strategies to balance the screening benefits with potential harms.
Methods: A cross-sectional, population-based diagnostic study was conducted in rural Xinjiang, China involving 8,638 women ≥ 25 years of age who participated in organized cervical cancer screening between 2023 and 2024. The study evaluated the accuracy and efficiency of multiple HPV-based "screen-triage" strategies. Histologically confirmed cervical intraepithelial neoplasia grade 2 or worse (CIN2+ and CIN3+) served as disease outcomes.
Results: Among single-step triage strategies, only extended genotyping for the seven most carcinogenic HPV types (HPV16/18/31/33/45/52/58) maintained sensitivity for CIN2+ comparable to HPV screening without triage (90.0% vs. 92.5%, P = 0.50) but significantly improved specificity (94.7% vs. 90.8%, P < 0.001). This approach led to a 38% reduction in colposcopy referrals (relative rate, 0.62; 95% CI: 0.59-0.65). Two-step triage algorithms (HPV16/18 with reflex ASC-US+ or methylation) showed slightly lower but non-significant sensitivity (87.5%, P = 0.13/89.6%, P =0.50) than HPV primary screening without triage, yet achieved significantly increased specificity (> 95%, P < 0.001) and reduced colposcopy referral by ~50% (relative rate, 0.5; P < 0.001). If negative for cytology or methylation, women positive for 12 high-risk HPV types (excluding HPV16/18) had a < 2% risk of CIN2+ (CIN3+ risk < 1%), indicating delayed follow-up.
Conclusions: Focusing on the seven high-risk HPV types within a one-step "screen-triage" framework effectively balances minimal sensitivity loss with significant gains in specificity, reducing unnecessary referrals and treatments, especially valuable in resource-limited settings. Integrating HPV genotyping with methylation results improves the accurate identification of women requiring immediate referral, which is advisable when resources allow.
期刊介绍：
Cancer Biology & Medicine (ISSN 2095-3941) is a peer-reviewed open-access journal of Chinese Anti-cancer Association (CACA), which is the leading professional society of oncology in China. The journal quarterly provides innovative and significant information on biological basis of cancer, cancer microenvironment, translational cancer research, and all aspects of clinical cancer research. The journal also publishes significant perspectives on indigenous cancer types in China.
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